Product Description
Features:
High transparent pp
provides clear graduation visibility.
Full automation assemble
line makes mass production easily.
The patented safety
mechanism is an integrated part of the syringe without add-on
pieces.
Tab at the end prevents
pre-activation during transportation or before
injection.
Benefits:
Clinicians’ hands and
fingers remain behind the sharp at all times
Minimal dead space,
Minimize waste in medication
The needle is securely
protected inside the barrel and remains protective during
disposal.
No Recapping
required.
Largely save on disposal
cost
Usage
instruction:
1,Remove the needle
cover
2,Draw up medication as per
protocol
3,Remove the confining
piece
4,Remove air
bubbles
5,Push the plunger to inject
and lock the needle when medication finished
6,Withdraw the plunger to draw
back the needle into the barrel
7,Break off the
plunger
8,The syringe has been totally
disabled
ABOUT US:
Classic Medical is the pioneer safety injection products and
service provider company in the world with efforts continuously
being put on the developing and researching of safety injection
solutions.
Since the establishment of year ***2, we have been promoting safety
injection globally with the commitment of making safety injection
within reach for all.
With this commitment in mind we have during these years providing
safety syringes to both domestic governments and overseas at
economic price and superior quality, help billions get safety
injection by providing unmatched value products and outstanding
service.
In Classic Medical, we believe exceptional service and product
quality can make theirbest value when combining with social
responsibility.
We will consistently do what have been doing and go beyond
1 Introduction of the
company
1.1 Overview of the
company
The
reformation of international and domestic medical device for single
use market is coming. The R&D team established the
“single Use Medical Device Improvement Institute” in Shanghai
in ***0, which mainly focus on R&D and improvement of single
use medical devices. In ***3, the first product
“TS-ARetractable Safety Syringe Single Use Only” with
patent was completed， and the patent application was submitted to
National Intellectual Asset Bureau.
To
hold the coming of domestic and international market
opportunity,Classic Medical Tech (SHA) Co., Ltd. was
established in Dec. of ***3. The personnel include personnel of
original R&D personnel of Jinyue Institute, specialists from
various scope, including overseas personnel back to China, nurses,
R&D management personnel more than *0 persons. Other than
strong R&D force, the company has the stage planning for new
product marketing, the objective is holding a certain market share
in 2 years.
The products in marketing of our company will all have
independent intellectual asset. This plentiful immateriality asset
will be the first backbone of our company to enter the capital
market in the future.
The quality policy of our company is：
“Accurate and fine,
scientific and creative”
The quality objective of our company is：
① Establish a perfect quality
management system，effectively implement and continually
improve，ensure the certification of ISO
****5:***3《Medical
devices — Quality managementsystems — Requirements for
regulatorypurposes》 and 《Medical Device
Directive of EC》（ *3/*2/EEC:***3）.
② Take the 6σ as quality
management measure, pursue the best level of international；quality
level achieves 3σ in 1 year.
③ The product quality
conforming to national requirement, and the conformity rate in
inspection for delivery achieve **0%.
1．2 The
company
Address:Room
**-D,No.2,Lane **0,TianShan Road, ChangNing District, ShangHai,
Chin
Postal
code：*****5
Tel：*************1
Fax：*************1
1．3 EC-representative
Name of
EC-representative：Eastland Medical System
PLC
Address of EC-representative：Suite 9, The Royal *5 Bank
Plain，
Norwich，Norfolk， NR*4SF，United
Kingdom
Tel：
*4 (***3) **3
**9
Fax： **4 (***3)
**6 **9
2 Description of the
product
2.1 Description of the
product
The syringe
for single use is a common product widely used in domestic and
international medical units. The Retractable Safety Syringe Single
Use Only manufactured by our company use same raw materials with
common syringe for single use, it is not a completely new product,
it just improves the exist product and adds the safety and
self-destroy function after injection.
2.2 Components of the
product
The
components of product include coat, needle tube, needle stand,
protective coat and piston.
2.3 Intended use of the
product
The
Retractable Safety Syringe Single Use Only is used for clinical
injection for sufferer. The injection process is very same as
traditional syringe, the difference is after injection, the needle
tube is retractable to ensure single use and prevent cross
infection in injection.
3 Pattern of the product
（see Fig. 1）
1—zero scale
line；2—sub-scale volume
line；3—nominal volume scale
line；4—general volume scale
line；5—base
line；6—coat roll edge;
7—needle
tube；8—coat
neck；
9—needle
stand；*0—coat；*1—stick
head；*2—metallic hook；*3—piston；*4—stick；*5—handle；*6—coat；*7—protective piece
Note：This
sketch map is only for illustrating structure of
syringe，not indicate the only pattern specified by
standard.
Fig. 1 Retractable Safety Syringe Single Use Only
4 Performance of the
product
4.1 The Retractable Safety
Syringe Single Use Only is improved based on traditional syringe
for single use.
4.1.1 There added a stick head
on stick part, and assembly a metallic hook.
4.1.2 The match of needle stand and coat was changed from
assembly inside to assembly outside.
4.1.3 There is break fracture
and protective piece.
4.2 The raw materials and
production technique is basically same as traditional syringe for
single use.
4.3 Performance other than
safety and self-destroy please refer to ISO *****1：***3/ GB
****0—***1《Sterile Syringe for Single Use》和ISO ***4：***3/ GB
****1—***1《Sterile Syringe Needle for Single Use》.
4.4 The structure and safety
and self-destroy function of Retractable Safety Syringe Single Use
Only refers the needle stand assembled in inside of coat neck.
After injection, the metallic hook on head of stick inserts the
needle stand, the stick will lock with needle stand which causes
destroy, pull back the stick at that time, the needle tube will
retract to coat completely, which achieves safety function.
5 Precautions
in use of the product
5.1 Use before expiry date. Use
after expiry date is forbidden；
5.2 Check if there is foreign
substrates in unit package before use. Do not use if there is
foreign substrate；
5.3 For single use only. Use
immediately after unit package opened；
5.4 Do not use if package is
broken.
5.4 Do not use if there is
other abnormal issues.
5.5 Store the product with
conditions of humidity not more than *0%，temperature not
higher than *0℃，no erosive gas and with good aeration. The
humidity-proofing and disinfection-proofing shall be
considered.
6 Specifications of the
product
There are 8
specifications of Retractable Safety Syringe Single Use Only:
0.1ml,0.3ml,0.5ml, 1ml,2ml, 3ml, 5ml, *0ml.
7 Accessories and package of
the product
Each Retractable Safety Syringe Single Use Only is packaged in a
unit package. Each **0～**0 unit packages are put in middle
package, and each 6～8 middle packages are put in outer package
because of the limitation of size.
8 Classification of the
product
According to
classification rule of 《Medical Device
Directives》（*3/*2/EEC:***3）, the Retractable Safety Syringe Single
Use Only manufactured by our company is classified as Class Ⅱa
product.
9 Conformity routine of the
product
Select the certification routine according to 《Medical Device
Directives》（*3/*2/EEC:***3）Annex II.
| Country: |
China |
| Model No: |
3ml
|
| FOB Price: |
175 / Piece (Negotiable)
Get Latest Price
|
| Place of Origin: |
CHINA |
| Price for Minimum Order: |
175 per Piece |
| Minimum Order Quantity: |
200000 Piece |
| Packaging Detail: |
PE |
| Delivery Time: |
- |
| Supplying Ability: |
- |
| Payment Type: |
T/T, L/C |
| Product Group : |
- |
